Dosage of Topilex 200 mg in details
Monotherapy Use
Adults and Pediatric Patients 10 Years and Older with Partial Onset or Primary Generalized Tonic-Clonic Seizures
The recommended dose for Topilex 200 mg monotherapy in adults and pediatric patients 10 years of age and older is 400 mg orally once daily. Titrate Topilex 200 mg Extended-Release Capsules according to the following schedule:
Adjunctive Therapy Use
Adults (17 Years of Age and Older) - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
The recommended total daily dose of Topilex 200 mg Extended-Release Capsules as adjunctive therapy in adults with partial onset seizures or Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily. The recommended total dose for adults with primary generalized tonic-clonic seizures is 400 mg orally once daily.
Initiate therapy at 25 mg to 50 mg once daily followed by titration to an effective dose in increments of 25 mg to 50 mg every week. Daily Topilex 200 mg doses above 1,600 mg have not been studied.
In the study of primary generalized tonic-clonic seizures using Topilex 200 mg, the assigned dose was reached at the end of 8 weeks.
Pediatric Patients (Ages 2 Years to 16 Years) - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
The recommended total daily dose of Topilex 200 mg Extended-Release Capsules as adjunctive therapy for pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 mg/kg to 9 mg/kg orally once daily. Begin titration at 25 mg once daily (based on a range of 1 mg/kg/day to 3 mg/kg/day) given nightly for the first week. Subsequently, increase the dosage at 1 or 2 week intervals by increments of 1 mg/kg to 3 mg/kg to achieve optimal clinical response. Dose titration should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.
In the study of primary generalized tonic-clonic seizures, the assigned dose of 6 mg/kg once daily was reached at the end of 8 weeks.
Dose Modifications in Patients with Renal Impairment
In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.
Prior to dosing, obtain an estimated creatinine clearance (CrCl) in patients at high risk for renal insufficiency (e.g., older patients, or those with diabetes mellitus, hypertension, or autoimmune disease). CrCl can be estimated using the following equation (multiply by 0.85 for women):
Dosage Modifications in Patients Undergoing Hemodialysis
Topilex 200 mg is cleared by hemodialysis at a rate that is 4 to 6 times greater than in patients with normal renal function. Accordingly, a prolonged period of dialysis may cause Topilex 200 mg concentration to fall below that required to maintain an anti-seizure effect. To avoid rapid drops in Topilex 200 mg plasma concentration during hemodialysis, a supplemental dose of Topilex 200 mg may be required. The actual adjustment should take into account the:
- duration of dialysis period
- clearance rate of the dialysis system being used
- effective renal clearance of Topilex 200 mg in the patient being dialyzed.
Laboratory Testing Prior to Treatment Initiation
Measurement of baseline and periodic serum bicarbonate during treatment with Topilex 200 mg Extended-Release Capsules is recommended.
Dosing Modifications in Patients Taking Phenytoin and/or Carbamazepine
The co-administration of Topilex 200 mg Extended-Release Capsules with phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with Topilex 200 mg Extended-Release Capsules may require adjustment of the dose of Topilex 200 mg Extended-Release Capsules.
Monitoring for Therapeutic Blood Levels
It is not necessary to monitor Topilex 200 mg plasma concentrations to optimize therapy with Topilex 200 mg Extended-Release Capsules.
Administration Instructions
Topilex 200 mg Extended-Release Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. This drug/food mixture should be swallowed immediately and not chewed or crushed. Do not store drug/food mixture for further use. Topilex 200 mg Extended-Release Capsules can be taken without regard to meals.
What other drugs will affect Topilex 200 mg?
Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by Topilex 200 mg. Tell your doctor if you regularly use any of these medicines, or any other seizure medication.
Tell your doctor about all other medicines you use, especially:
- lithium (Eskalith, LithoBid);
- hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic);
- metformin (Glucophage, Actoplus Met, Avandamet, Fortamet, Janumet, PrandiMet, Riomet);
- atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
- bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
- bladder or urinary medications such as darifenacin (Enablex), solifenacin (Vesicare), and others;
- glaucoma medications such as acetazolamide (Diamox) or methazolamide (Neptazane); or
- other seizure medications such as carbamazepine (Carbatrol, Equetro, Tegretol), lamotrigine (Lamictal), phenytoin (Dilantin), divalproex sodium (Depakote), valproic acid (Depakene, Stavzor), or zonisamide (Zonegran).
This list is not complete and other drugs may interact with Topilex 200 mg. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Topilex 200 mg interactions
Oral Contraceptives
The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Topilex 200 mg. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding.
Antiepileptic Drugs
Concomitant administration of phenytoin or carbamazepine with Topilex 200 mg decreased plasma concentrations of Topilex 200 mg.
Concomitant administration of valproic acid and Topilex 200 mg has been associated with hyperammonemia with and without encephalopathy. Concomitant administration of Topilex 200 mg with valproic acid has also been associated with hypothermia (with and without hyperammonemia) in patients who have tolerated either drug alone. It may be prudent to examine blood ammonia levels in patients in whom the onset of hypothermia has been reported.
Numerous AEDs are substrates of the CYP enzyme system. In vitro studies indicate that Topilex 200 mg does not inhibit enzyme activity for CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4/5 isozymes. In vitro studies indicate that immediate-release Topilex 200 mg is a mild inhibitor of CYP2C19 and a mild inducer of CYP3A4. The same drug interactions can be expected with the use of Topilex 200 mg.
CNS Depressants And Alcohol
Topilex 200 mg is a CNS depressant. Concomitant administration of Topilex 200 mg with other CNS depressant drugs or alcohol can result in significant CNS depression. Concomitant use of alcohol should be avoided.
Other Carbonic Anhydrase Inhibitors
Concomitant use of Topilex 200 mg, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide, acetazolamide or dichlorphenamide), may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. Patients should be monitored for the appearance or worsening of metabolic acidosis when Topilex 200 mg is given concomitantly with another carbonic anhydrase inhibitor.
Metformin
Topilex 200 mg treatment can frequently cause metabolic acidosis, a condition for which the use of metformin is contraindicated. The concomitant use of Topilex 200 mg and metformin is contraindicated in patients with metabolic acidosis.
Lithium
In patients, there was an observed increase in systemic exposure of lithium following Topilex 200 mg doses of up to 600 mg per day. Lithium levels should be monitored when co-administered with high-dose Topilex 200 mg.
Drug Abuse And Dependence
Controlled Substance
Topilex 200 mg (Topilex 200 mg) extended-release capsule is not a controlled substance.
Abuse
The abuse and dependence potential of Topilex 200 mg has not been evaluated in human studies.
Dependence
Topilex 200 mg has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.
References
- DailyMed. "TOPIRAMATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "0H73WJJ391: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Neuroprotective Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Topilex 200 mg are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Topilex 200 mg. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported frequency of use
No survey data has been collected yetConsumer reported doses
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
